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Stem Cells Transl Med. 2014 May;3(5):560-3. doi: 10.5966/sctm.2013-0180. Epub 2014 Mar 28.

Progressive approval: a proposal for a new regulatory pathway for regenerative medicine.

Author information

1
Skeletal Research Center, Biology Department, Case Western Reserve University, Cleveland, Ohio, USA.

Abstract

To stimulate a broad discussion between academics, practicing physicians, corporate managers, and members of the regulatory community, we describe a proposal for a new regulatory pathway for human cell- and tissue-based products. The new components of the pathway are intended to accelerate patient access to a wide array of novel therapeutics, strengthen R&D infrastructure, and expand patient numbers and time lines for efficacy testing through a transparent and publicly accessible website for real-time reporting of outcome data and 5- to 10-year, long-term follow-up.

PMID:
24682285
PMCID:
PMC4006487
DOI:
10.5966/sctm.2013-0180
[Indexed for MEDLINE]
Free PMC Article

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